Unauthorized Use of Content on this Site: The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB)—including, but not limited to, those available through the PAAB Forum, the PAAB website, and any PAAB correspondence—are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content, or using it for model training or any related purposes, is strictly prohibited without the express prior written consent of PAAB. This includes, but is not limited to, the use of such materials in automated systems, machine learning models, or artificial intelligence applications.
Wallet Card carried by patients, provided by HCPs for HCPs
-
Hello! We are creating a folded wallet card for patients to carry in case of hospitalization. The intent is that the card would be delivered to HCPs to give to their patients, who will keep it in their wallet to have on hand for attending HCPs should the need arise.
The first panel states that the patient is on drug name and has fields for patient name, physician name and phone number, and a field to indicate when they take it. It does not mention therapeutic area.
The second panel has a QR code that links to a complete, unedited product monograph PDF (the same link that would be in a fair balance statement), intended for HCPs to have quick access in case of emergency.
Q: Given that HCPs are the intended audience of the piece, not the patient carrying the card, does this piece require low-level fair balance?
-
Good Morning @tf
This is a specific review question. Consider general guiding principles that patient pieces do not have “fair balance” but still need to be balanced and complete. HCP-directed material should be assessed using the Guidance on base fair balance level selection and placement document. Assessment of the need for fair balance would occur during the review process.
-
@jennifer-carroll Thank you!
